New generic of Ofev for IPF approved by FDA, slated for ‘immediate’ launch
Cipla's nintedanib capsules will be available in US at 2 dose strengths
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The U.S. Food and Drug Administration (FDA) has approved a generic version of Ofev (nintedanib) for easing lung scarring in people with idiopathic pulmonary fibrosis (IPF).
The new generic nintedanib oral capsules, available in 100 mg and 150 mg dosages, will be marketed by Cipla. In a press release announcing the drug’s regulatory approval in the U.S., the company said that the new generic “will be available through appropriate pharmacy distribution channels, including specialty distribution.”
Cipla said “the company is set to launch on an immediate basis.”
Marc Falkin, CEO of Cipla North America, said the new approval “strengthens our respiratory franchise and reflects our continued commitment to delivering high-quality therapies to patients.”
“We are well prepared with a robust supply plan to support a successful launch,” Falkin added.
Pulmonary fibrosis refers to fibrosis, or scarring, in the lungs. The lungs normally need to be elastic and stretchy like balloons, which allows them to fill with air when a person inhales. Scar tissue, however, is thick and stiff, and when the lungs become scarred, they aren’t as stretchy so they can’t inflate with air as well.
Scar tissue can also interfere with the lungs’ ability to get enough oxygen out of air, and these effects combine to cause symptoms such as shortness of breath. IPF is a form of pulmonary fibrosis that is idiopathic, meaning the underlying cause of the disease is not known.
No pricetag announced yet for new Ofev generic
Ofev is an oral therapy that was first approved by the FDA more than a decade ago as a treatment for IPF. The therapy, which is also widely available in other countries, works through a number of mechanisms, including by blocking the activity of signaling molecules that help to drive fibrosis.
The medication was proven in clinical trials to help slow the decline of lung function in IPF. Common side effects of Ofev include diarrhea, nausea, abdominal pain, vomiting, decreased appetite, headache, and weight loss. Liver damage and high blood pressure can also occur with the medication’s use.
The name-brand drug is sold by Boehringer Ingelheim. As a generic, Cipla’s new therapy is chemically identical to that medication.
Typically, generic therapies are cheaper than name-brand medicines, and because they introduce more competition into the pharmaceutical marketplace, they may help to drive down costs overall.
Cipla did not specify what the cost of its new generic will be, though the company noted that sales from Ofev in the U.S. have generated approximately $3.76 billion.
